Glossaries
Glossaries
| Term | Definition |
|---|---|
| dynamic HTML |
Collective term for a combination of tags and options, style sheets, and programming that allows users to create web pages in hypertext Mark-up language (HTML) that are more responsive to user interaction than previous versions of HTML.
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| drug product |
A finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo. [21CFR210.3] See also medicinal product, dosage form.
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| drug distribution |
In pharmacokinetics, the processes that control transfer of a drug from the site of measurement to its target and other tissues. See also ADME.
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| drug development process |
The program for advancing an investigational product from preclinical studies through approval for marketing following review by regulatory agencies.
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| drug |
An active natural, synthetic or semi-synthetic ingredient including endogenous body substance that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient [21 CFR 314.3(b)]. See also medicinal product, active substance.
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| dropout |
A subject in a clinical trial who for any reason fails to continue in the trial until the last visit or observation required of him/her by the study protocol. [from ICH E9]
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| double-dummy |
A technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be made identical. supplies are prepared for Treatment a (active and indistinguishable placebo) and for Treatment B (active and indistinguishable placebo). subjects then take two sets of treatment; either a (active) and B (placebo), or a (placebo) and B (active). [ICH E9]
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| double-blind study |
A study in which neither the subject nor the investigator nor the research team interacting with the subject or data during the trial knows the treatment a subject is receiving. [After FDA Glossary of Terms]
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| dose-escalation trial |
A study in which the dosage of the test article is increased until the desired physiological effect or toxicity is seen. (CDISC; After ICH E4)
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| dose strength |
The strength of a drug product, which indicates the amount of each active ingredient in a single dose. For liquids, it is the proportion of each active substance to the volume of a liquid dosage form. [After FDA Glossary of Terms]
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| dose |
Specified quantity of a medicine, to be taken at one time or at stated intervals. [ISO 11615:2012 Health Informatics]
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| dosage regimen |
The schedule of doses of an agent per unit of time, including the number of doses per given time period and the elapsed time between doses. NOTE: For example, every six hours or the time that the doses are to be given (for example, at 8 a.m. and 4 p.m. daily); and/or the amount of a medicine (the number of capsules, for example) to be given at each specific dosing time. [After AMA Manual of Style]
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| dosage form |
Physical characteristics of a drug product, (e.g., tablet, capsule, or solution) that contains a drug substance, generally-but not necessarily-in association with one or more other ingredients. [21 CFR 314.3 and after IDMP]. See also drug product.
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dose form; pharmaceutical form |
| dosage |
The amount of drug administered to a patient or test subject over a period of time; a regulated time bound administration of individual doses. NOTE: For example, a daily dosage specified in a prescription or a clinical trial, such as one 100mg tablet taken 4 times per day. [After AMA Manual of style]
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| domain name |
The way a particular web server is identified on the internet. For example, www.fda.gov names the World Wide Web (www) server for the Food and Drug administration, which is a government (.gov) entity. [Center for advancement of Clinical Research]
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